Amgen Prevails in Patent Fight Over Its Anemia Drug

The Supreme Court on Monday refused to hear a patent appeal case involving biotechnology’s best-selling drug, securing Amgen Inc.’s near-monopoly on the drug.

The decision closed a four-year legal battle between Amgen and rival Genetics Institute Inc. over rights to the anti-anemia drug erythropoietin.

“The company is very pleased the Supreme Court has reaffirmed our position,” said Art Staubitz, Amgen’s senior vice president and general counsel. “The message to the biotechnology industry is its technology will be protected.”

Amgen, based in Thousand Oaks, saw its stock close Monday at $54.875 per share, up $2. The stock of Genetics Institute, based in Cambridge, Mass., declined $1.375 per share to $38.125. Both are traded over the counter.

EPO is a biotechnology-made copy of a human protein that circulates in the bloodstream and triggers production of red blood cells. Patients suffering from kidney disease can’t produce enough of the oxygen-carrying red blood cells and are chronically anemic and often bedridden. Since Amgen’s drug was approved for sale in June, 1989, EPO has proved to be a remarkable tonic in restoring the patients’ lost energy.

Estimates are that Amgen’s sales of the drug, which goes by the brand name Epogen, will reach $400 million this year. In the United States, Amgen has a monopoly on the biggest EPO market--treating kidney dialysis patients. Under a marketing agreement, a unit of Johnson & Johnson sells Amgen’s drug in the United States for other uses, such as treating anemia from chemotherapy.

The legal dispute over EPO began in 1987 when Amgen and Genetics Institute were granted different patents.

EPO was uncovered by scientists in 1906, but until biotechnology it was impossible to produce enough to use as a drug. In 1983 Amgen scientist Fu-Kuen Lin isolated the gene that produces EPO and, by splicing that gene with hamster cells, Amgen was able to manufacture EPO in the laboratory. Amgen’s patent covered the host cell that begins the EPO biotechnology process.

Genetics Institute’s patent covered a different route and involved a purified form of EPO separated from urine--even though not enough of the drug could be produced for commercial use by this method. Still, in court Genetics Institute argued that its patent covered Amgen’s biotech version of EPO.

Later Genetics Institute figured out how to manufacture the drug using biotechnology and licensed it to a U.S. joint venture between Upjohn Co. and Japan’s Chugai Pharmaceutical.

In December, 1989, a federal judge in Boston ruled that both the Amgen and Genetics Institute patents were valid. Amgen appealed. In March a federal appeals court in Washington upheld Amgen’s EPO patent and invalidated the one held by Genetics Institute.

Genetics Institute made one last legal attempt to prevail, retaining well-known constitutional law professor Laurence Tribe to submit its case to the Supreme Court. However, the court rarely hears patent cases, and it rejected the appeal without comment.